Diagnostic performance of the STANDARD™ Q Dengue DUO rapid diagnostic test in a resource-limited setting: a laboratory-based evaluation in the Republic of Niger.
- 1Virology Unit, Centre de Recherche Médicale et Sanitaire (CERMES), BP 10887, 634 Boulevard de la Nation YN034, Niamey, Niger. [email protected].
- 2Africa Center of Excellence on Neglected Tropical Diseases and Forensic Biotechnology (ACENTDFB), Department of Biochemistry, Faculty of Life Sciences, Ahmadu Bello University, Zaria, Kaduna, Nigeria.
- 3Virology Unit, Centre de Recherche Médicale et Sanitaire (CERMES), BP 10887, 634 Boulevard de la Nation YN034, Niamey, Niger.
Abstract
Background
Dengue fever is an expanding public health threat in sub-Saharan Africa, yet access to laboratory-confirmed diagnosis remains severely constrained in resource-limited settings. Rapid diagnostic tests (RDTs) offer a practical alternative to molecular and serological diagnostic methods, but their performance must be validated in local epidemiological contexts before integration into national testing algorithms.Methods
We conducted a retrospective laboratory-based diagnostic accuracy study using 221 archived serum samples from suspected dengue patients admitted to public and private hospitals in Niamey between October and December 2023. The STANDARD™ Q Dengue DUO (SD Biosensor) was compared against qRT-PCR (NS1 reference) and ELISA IgM (IgM reference). Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated with 95% Wilson score confidence intervals. Performance was stratified by viral load (Ct value) and time since symptom onset.Results
Dengue infection was confirmed in 68/221 (30.8%) samples by qRT-PCR and 69/221 (31.2%) by IgM ELISA. For NS1 detection, the STANDARD™ Q demonstrated sensitivity of 79.4% (95% CI: 68.4-87.3%) and specificity of 85.5% (95% CI: 78.0-90.7%), with sensitivity increasing to 83.8% when combined with IgM. NS1 sensitivity was highest in samples with low and moderate viral load (Ct 20-30: 100%). NS1 sensitivity was 84.4% in the acute phase (≤ 7 days) versus 57.1% in the recovery phase (> 7 days). For IgM detection, sensitivity was 49.3% (95% CI: 38.2-60.4%) but specificity was 98.6% (95% CI: 95.0-99.6%), with IgM sensitivity rising to 100% in the recovery phase.Conclusion
The STANDARD™ Q Dengue DUO demonstrated adequate NS1 accuracy and high IgM specificity. Combined NS1 and IgM testing improves case detection across infection phases. Thus, we recommend this RDT as a first-line diagnostic tool in decentralized healthcare settings in Niger, although molecular testing remains essential for surveillance and serotyping purposes.
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BibTeX
@article{lagare2026diagnostic,
title = {{Diagnostic performance of the STANDARD™ Q Dengue DUO rapid diagnostic test in a resource-limited setting: a laboratory-based evaluation in the Republic of Niger.}},
author = {Adamou Lagare and Nassirou Seyni Hamani and Fatimata Hassane and Hadiza Ousmane and Absatou Daouda Ousseini and Balki Aoula and Moussa Issa and Hassane Ousmane and Abdullahi Balarabe Sallau and Aliyu Muhammad},
journal = {BMC infectious diseases},
year = {2026},
month = aug,
doi = {10.1186/s12879-026-14158-w},
url = {https://europepmc.org/article/MED/42968030},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Diagnostic performance of the STANDARD™ Q Dengue DUO rapid diagnostic test in a resource-limited setting: a laboratory-based evaluation in the Republic of Niger.
AU - Adamou Lagare
AU - Nassirou Seyni Hamani
AU - Fatimata Hassane
AU - Hadiza Ousmane
AU - Absatou Daouda Ousseini
AU - Balki Aoula
AU - Moussa Issa
AU - Hassane Ousmane
AU - Abdullahi Balarabe Sallau
AU - Aliyu Muhammad
PY - 2026
DA - 2026/08/03
JO - BMC infectious diseases
DO - 10.1186/s12879-026-14158-w
UR - https://europepmc.org/article/MED/42968030
AB - Background Dengue fever is an expanding public health threat in sub-Saharan Africa, yet access to laboratory-confirmed diagnosis remains severely constrained in resource-limited settings. Rapid diagnostic tests (RDTs) offer a practical alternative to molecular and serological diagnostic methods, but their performance must be validated in local epidemiological contexts before integration into national testing algorithms.Methods We conducted a retrospective laboratory-based diagnostic accuracy study using 221 archived serum samples from suspected dengue patients admitted to public and private hospitals in Niamey between October and December 2023. The STANDARD™ Q Dengue DUO (SD Biosensor) was compared against qRT-PCR (NS1 reference) and ELISA IgM (IgM reference). Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated with 95% Wilson score confidence intervals. Performance was stratified by viral load (Ct value) and time since symptom onset.Results Dengue infection was confirmed in 68/221 (30.8%) samples by qRT-PCR and 69/221 (31.2%) by IgM ELISA. For NS1 detection, the STANDARD™ Q demonstrated sensitivity of 79.4% (95% CI: 68.4-87.3%) and specificity of 85.5% (95% CI: 78.0-90.7%), with sensitivity increasing to 83.8% when combined with IgM. NS1 sensitivity was highest in samples with low and moderate viral load (Ct 20-30: 100%). NS1 sensitivity was 84.4% in the acute phase (≤ 7 days) versus 57.1% in the recovery phase (> 7 days). For IgM detection, sensitivity was 49.3% (95% CI: 38.2-60.4%) but specificity was 98.6% (95% CI: 95.0-99.6%), with IgM sensitivity rising to 100% in the recovery phase.Conclusion The STANDARD™ Q Dengue DUO demonstrated adequate NS1 accuracy and high IgM specificity. Combined NS1 and IgM testing improves case detection across infection phases. Thus, we recommend this RDT as a first-line diagnostic tool in decentralized healthcare settings in Niger, although molecular testing remains essential for surveillance and serotyping purposes.
SN - 1471-2334
ER -